Alcohol in BreastmilkNCT01246661
MilkScreen™ Home Test for Alcohol in Breast Milk Clinical Study
An observational study of Alcohol in Breastmilk, run by UpSpring Baby, Ltd..
Trial summary
The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to detect alcohol in breast milk that will be donated during this study. This research is being done because the sponsoring company, UpSpring, wants to determine if this test will work and, if it does, how well it will work to… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol in Breastmilk
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female subjects 21 years and older will be recruited for this study.
Who may be able to join
- Female
- Age equal to or greater than 21 years
- Actively breast-feeding
- Willing to drink at least one alcoholic beverage (wine or beer) during study in a controlled setting
- Willing to arrive to the study session prior to consuming any alcoholic beverages within the last 24 hours.
- Willing to attend single session study for 3-4 hours duration until their BAC drops below 0.06%
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- Willing to accept designated driver or study-supplied transportation
- Willing to agree to not breast feed their infant for 2 hours following departure from the study session
- English language fluency
Who cannot join
- Distance of more than 25 miles from study site
- Pregnant (pregnancy test will be administered at time of study)
- Communicable diseases (e.g., Flu)
- HIV Positive
- History of Alcoholism
- Arriving to the study session with a BAC at or above 0.01%
- Any medical condition which precludes the subject from drinking alcohol
- Skilled or trained in clinical laboratory procedures
About this study
The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to detect alcohol in breast milk that will be donated during this study. This research is being done because the sponsoring company, UpSpring, wants to determine if this test will work and, if it does, how well it will work to detect levels of alcohol in breast milk.
Read the detailed description
MilkScreen™ Home Test for Alcohol in Breast Milk is intended as an OTC test for the presence of alcohol in breast milk. This study will obtain data to demonstrate the agreement of MilkScreen™ compared to the reference method, head space Gas Chromatography-Mass Spectrometry (GC-MS) for alcohol content and will additionally provide validation of the usability of the device by the intended users.
The study will use a minimum of 50 lactating mothers who will come into a center in small groups in a contrived social setting like a wine tasting. Upon completion of informed consent and demonstration of meeting inclusion/exclusion criteria, subjects will be tested with disposable breathalyzer test and baseline breast milk samples provided. The baseline breast milk samples will be tested with the test article by the subject. Aliquots from the same samples will be prepared for testing by an outside lab with GC-MS.
Subjects will be asked to provide baseline demographics such as height and weight, days since birth of child, race/ethnicity, and information about any prescription or OTC drugs, herbal compounds or vitamins they have taken in the previous 72 hours.
Subjects will be provided with up to 3 alcoholic beverages over the course of a three to four hour period. At prescribed time intervals following consumption, subjects will be asked to provide a breast milk sample and to submit to a breathalyzer test. Each breast milk sample will be tested by the subject with the test article following the labeling instructions only and the sample will also be aliquoted into tightly sealing, low head space sample containers for method comparison testing by an outside lab with GC-MS.
Subjects will be asked to drink at least one drink, but may ingest up to two additional alcoholic beverages during the course of the study. Each subject's blood alcohol content (BAC) will be monitored before each additional drink is provided and will not be allowed to consume additional drinks if their BAC as measured by the disposable breathalyzer device exceeds 0.10% (100 mg/dL). All drinks will be prepared such that they contain alcohol consistent with a standard alcoholic drink, as defined by the National Institute on Alcohol Abuse and Alcoholism (12 ounces of beer, 8-9 ounces of malt liquor, 5 ounces of table wine, or 1.5 ounces of liquor). Subjects will be asked to self report whether they finished their drink at the point when samples are taken. Subjects will be provided with transportation to and from the study site using designated non-drinking drivers.
Samples of breast milk taken both prior to and following the ingestion of alcohol will be coded and thereby blinded to the lab. The lab will run GC-MS on each specimen and will report the results to the Sponsor. This data will be compared with the data reported by each subject and analyzed to demonstrate that the MilkScreen™ Home Test for Alcohol in Breast Milk agrees to a high degree to the reference method, GC-MS, to support the test article's intended use.
Subjects will be asked to complete a questionnaire on the usability of the labeling instructions on MilkScreen™ Home Test for Alcohol in Breast Milk to demonstrate that consumers can use the directions properly to test their breast milk for the presence of alcohol and properly interpret the results.
- Conditions
- Alcohol in Breastmilk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol in BreastmilkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UpSpring Baby, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246661
- Sponsor's protocol ID
- 4001-002
- Status last verified
- Nov 2010
- First submitted
- 22 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MilkScreen™ Home Test for Alcohol in Breast Milk Clinical Study
- ClinicalTrials.gov ID
- NCT01246661
- Acronym / sponsor ID
- 4001-002
- Conditions
- Alcohol in Breastmilk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UpSpring Baby, Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Nov 2010 (estimated)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to detect alcohol in breast milk that will be donated during this study. This research is being done because the sponsoring company, UpSpring, wants to determine if this test will work and, if it does, how well it will work to detect levels of alcohol in breast milk.
Detailed description
MilkScreen™ Home Test for Alcohol in Breast Milk is intended as an OTC test for the presence of alcohol in breast milk. This study will obtain data to demonstrate the agreement of MilkScreen™ compared to the reference method, head space Gas Chromatography-Mass Spectrometry (GC-MS) for alcohol content and will additionally provide validation of the usability of the device by the intended users.
The study will use a minimum of 50 lactating mothers who will come into a center in small groups in a contrived social setting like a wine tasting. Upon completion of informed consent and demonstration of meeting inclusion/exclusion criteria, subjects will be tested with disposable breathalyzer test and baseline breast milk samples provided. The baseline breast milk samples will be tested with the test article by the subject. Aliquots from the same samples will be prepared for testing by an outside lab with GC-MS.
Subjects will be asked to provide baseline demographics such as height and weight, days since birth of child, race/ethnicity, and information about any prescription or OTC drugs, herbal compounds or vitamins they have taken in the previous 72 hours.
Subjects will be provided with up to 3 alcoholic beverages over the course of a three to four hour period. At prescribed time intervals following consumption, subjects will be asked to provide a breast milk sample and to submit to a breathalyzer test. Each breast milk sample will be tested by the subject with the test article following the labeling instructions only and the sample will also be aliquoted into tightly sealing, low head space sample containers for method comparison testing by an outside lab with GC-MS.
Subjects will be asked to drink at least one drink, but may ingest up to two additional alcoholic beverages during the course of the study. Each subject's blood alcohol content (BAC) will be monitored before each additional drink is provided and will not be allowed to consume additional drinks if their BAC as measured by the disposable breathalyzer device exceeds 0.10% (100 mg/dL). All drinks will be prepared such that they contain alcohol consistent with a standard alcoholic drink, as defined by the National Institute on Alcohol Abuse and Alcoholism (12 ounces of beer, 8-9 ounces of malt liquor, 5 ounces of table wine, or 1.5 ounces of liquor). Subjects will be asked to self report whether they finished their drink at the point when samples are taken. Subjects will be provided with transportation to and from the study site using designated non-drinking drivers.
Samples of breast milk taken both prior to and following the ingestion of alcohol will be coded and thereby blinded to the lab. The lab will run GC-MS on each specimen and will report the results to the Sponsor. This data will be compared with the data reported by each subject and analyzed to demonstrate that the MilkScreen™ Home Test for Alcohol in Breast Milk agrees to a high degree to the reference method, GC-MS, to support the test article's intended use.
Subjects will be asked to complete a questionnaire on the usability of the labeling instructions on MilkScreen™ Home Test for Alcohol in Breast Milk to demonstrate that consumers can use the directions properly to test their breast milk for the presence of alcohol and properly interpret the results.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects 21 years and older will be recruited for this study.
Key inclusion criteria (9 listed)
- Female
- Age equal to or greater than 21 years
- Actively breast-feeding
- Willing to drink at least one alcoholic beverage (wine or beer) during study in a controlled setting
- Willing to arrive to the study session prior to consuming any alcoholic beverages within the last 24 hours.
Key exclusion criteria (8 listed)
- Distance of more than 25 miles from study site
- Pregnant (pregnancy test will be administered at time of study)
- Communicable diseases (e.g., Flu)
- HIV Positive
- History of Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol in Breastmilk, run by UpSpring Baby, Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.